Macksofy Technologies
Hyderabad · VAPT
CERT-In EmpanelledHyderabad

VAPT Services in Hyderabad · Pharma & IT

CERT-In empanelled VAPT for HITEC City SaaS, Genome Valley pharma R&D and Telangana IT-services majors — built around regulated-data flows.

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South India engagements
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<0 hrs
Onsite SLA in city
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Local hub
HITEC City based
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QA + IT
Dual-signoff playbook
VAPT in Hyderabad

How a Macksofy vapt engagement runs in Hyderabad.

Hyderabad's cybersecurity demand splits cleanly along two axes and most generic 'VAPT vendors' miss the seam entirely. HITEC City, Gachibowli and Madhapur host the SaaS, fintech and IT-services majors. Genome Valley (Shameerpet, off the ORR exit to Karimnagar) and the broader Shamirpet–Patancheru pharma corridor host the R&D campuses and CROs that run clinical-trial data, GMP-validated lab systems and lab-instrument integrations. The same engagement template breaks against both: pharma scoping looks like a regulated-data-flow audit, SaaS scoping looks like a multi-tenant authz audit. Macksofy maintains two distinct playbooks and the senior consultant chooses which to pull off the shelf at kickoff.

For pharma and CRO clients in Genome Valley and the Patancheru belt, we focus on regulated-data flows end-to-end: clinical-trial portals (eCRF, EDC), eTMF systems, lab-instrument integrations (Empower, LabSolutions, OpenLAB CDS), the LIMS and the segregation between R&D networks and corporate IT. Findings are mapped to 21 CFR Part 11 (electronic-records and electronic-signature controls), GxP data-integrity ALCOA+ principles, EU GMP Annex 11 (computerised systems) and the WHO TRS 1019 Annex 4 guidance on data integrity. The same VAPT closes the next FDA Pre-Approval Inspection or EMA mock-audit cycle, which the QA director cares about far more than the IT director.

Lab-instrument testing is a Hyderabad specialty. Most pharma engagements include a walk-through of at least one QC lab — HPLC, GC, dissolution-tester and balance integrations into the LIMS or CDS. Common findings: shared local-admin credentials on the analytical workstation, USB-mass-storage policy gaps that allow raw-data exfiltration, audit-trail-disable paths on the chromatography software, and time-synchronisation drift between the instrument workstation and the LIMS server that breaks ALCOA+ contemporaneity. These do not appear in a Burp Suite report. We run them as guided walk-throughs with a QA witness and document the evidence in 21 CFR Part 11 §11.10(e) terms.

For HITEC City and Gachibowli SaaS and IT-services clients in Cyber Towers, Mindspace, Raheja Mindspace, Hitech City Phase 2 and the Q City / Wave Rock belt, scopes look more like the Bengaluru pattern — multi-tenant SaaS authz, customer-data isolation, vendor-API trust chains — but with a strong overlay of US-healthcare and US-BFSI client-imposed control catalogues passed down from US/EU parents. Reports map to SOC 2 Type II CC controls, ISO 27001:2022 Annex A and (where US healthcare data is in scope) HIPAA Security Rule §164.308–312 administrative, physical and technical safeguards.

Senior consultants fly from Mumbai BKC via the BOM-HYD morning flight; for Hyderabad-resident lead support we draw from the South India regional hub in HITEC City itself, which keeps onsite cadence inside two hours for any Madhapur, Gachibowli, Banjara Hills, Kondapur or Genome Valley location. Most pharma VAPTs run 4-5 weeks with at least two onsite plant or R&D-site visits; SaaS scopes complete in 3-4 weeks; full-suite pharma engagements that touch corporate IT plus R&D plus QC lab integrations stretch to 6-8 weeks. We re-test critical findings inside the remediation window at no extra cost.

Hyderabad pharma procurement is unusual: the IT head proposes the SoW, the QA director approves it (because 21 CFR Part 11 and ALCOA+ live in QA's jurisdiction), and the head of plant operations signs off if any GMP-validated system is in scope. We size proposals around that triangle and write the executive summary in QA-readable language — not 'CVSS 7.4 SSRF in eTMF' but 'electronic-record integrity exposure on the eTMF audit-trail path; FDA inspection risk Category-1; remediation closes 21 CFR Part 11 §11.10(e)'. Every finding is dated against the next FDA / EMA / DCGI inspection on the QA calendar so the team knows which gaps must close before which inspection.

For HITEC City SaaS and IT-services clients, procurement closes through the CTO and AppSec lead, sometimes with a US-headquartered parent's CISO copied for the larger GCCs. We sync the report to the next enterprise-procurement cycle and ship a sanitised vendor pack alongside the technical findings. Where the client also operates a parallel pharma-data scope (a CRO running a SaaS clinical-trial-management platform, for example), we shift methodology between SaaS-style and pharma-style scoping in the same engagement so the QA and AppSec functions get one report rather than two contradictory ones.

Genome Valley clients almost universally now run a parallel DPDP Act readiness track on clinical-trial-participant data. We layer DPDP RoPA mapping and consent-flow testing into the pharma VAPT — informed-consent capture, withdrawal-of-consent propagation back through the eTMF, and the cross-border-transfer evidence that DPDP §16 now requires for sponsor-data flows back to the US or EU CRO parent.

Engagement workflow

Five phases. Hyderabad timeline.

Every Macksofy vapt engagement in Hyderabad runs through the same phased protocol — adapted to Hyderabad-specific procurement, regulator and delivery realities.

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Phase 01
QA-Aware Scoping
  • Joint kickoff with IT head, QA director and (if GMP systems in scope) head of plant operations
  • Inspection-calendar map — FDA / EMA / DCGI dates pinned against finding-closure milestones
  • Pharma vs SaaS playbook selection — separate consultants and tool stacks where both are in play
  • Genome Valley / Shamirpet / HITEC City onsite-visit schedule and QA-witness arrangement
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Phase 02
Regulated-Data Discovery
  • Clinical-trial portal, eTMF and EDC inventory with electronic-record path mapping
  • LIMS, CDS and lab-instrument integration enumeration with QA walk-through
  • R&D / QC lab / corporate IT segregation review (network, AD, file-share, USB policy)
  • Sponsor-data flow inventory for DPDP §16 cross-border-transfer evidence
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Phase 03
Application & Authz
  • Multi-tenant SaaS authz testing for HITEC City product clients (Burp Pro, OWASP ASVS L2)
  • 21 CFR Part 11 audit-trail disable-path and ALCOA+ contemporaneity testing on eTMF and CDS
  • HPLC / GC / dissolution-tester workstation review — shared local-admin, USB policy, time-sync drift
  • PAS, EDC and eCRF role-based access control matrix exercised role-by-role
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Phase 04
Dual-Format Reporting
  • QA-readable executive summary in 21 CFR Part 11 / GMP Annex 11 / ALCOA+ language
  • AppSec-readable technical findings with Burp/curl repros and CWE references
  • SOC 2 Type II + ISO 27001:2022 Annex A + (where applicable) HIPAA crosswalk for the IT-services side
  • DPDP RoPA and §16 cross-border-transfer evidence pack for sponsor-data flows
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Phase 05
Inspection-Defence Re-test
  • Re-test of every Critical and High inside the FDA / EMA inspection window
  • Inspection-defence rehearsal — likely inspector questions per finding category
  • CERT-In empanelled closure letter formatted for DCGI submission where required
  • Sponsor-CRO data-flow memo for the parent's quality-and-cyber joint committee
Industries served

Which Hyderabad verticals we deliver VAPT for.

Pharma R&D & generics

Top-5 generics with Shameerpet R&D, Patancheru API plants and Bachupally formulations — IT + lab + GMP-system VAPT.

CROs & clinical-trial sites

Genome Valley CROs — eTMF, EDC, sponsor-data flow and DPDP §16 cross-border-transfer evidence.

HITEC City SaaS

Cyber Towers and Mindspace product companies — multi-tenant authz with SOC 2 Type II + ISO 27001:2022 alignment.

US-healthcare GCCs

Gachibowli and Q City BPO/GCC operations on US PHI — HIPAA Security Rule and HITRUST-aligned VAPT.

Telangana IT-services

Hyderabad-headquartered IT-services majors — parent-control-catalogue crosswalk on top of CERT-In format.

Banking GCCs

Kondapur and Gachibowli BFSI captive ops — RBI VAPT clauses applied to India-side GCC infrastructure.

What ships

The Hyderabad deliverable pack.

Every Hyderabad vapt engagement closes with the pack below — regulator-ready evidence, technical detail and board-readable summaries.

  • VAPT report in CERT-In empanelled format with 21 CFR Part 11 / GMP Annex 11 crosswalk for regulated systems
  • ALCOA+ data-integrity evidence on eTMF, LIMS and CDS audit-trail paths
  • Multi-tenant SaaS authz test results mapped to OWASP ASVS L2 and SOC 2 CC6/CC7
  • HIPAA Security Rule §164.308-312 evidence pack for US-healthcare GCC scopes
  • DPDP §16 cross-border-transfer evidence pack for sponsor-CRO data flows
  • Lab-instrument walk-through memos signed off by QA witness
  • Free re-test of every Critical and High inside the next FDA / EMA inspection window
  • Inspection-defence rehearsal pack with likely inspector questions per finding category
Recent Hyderabad engagement

A Hyderabad vapt case study.

Top-5 Indian generics major (Shameerpet R&D + Bachupally formulations)
Scope

Pharma VAPT across eTMF, EDC, LIMS, three QC lab CDS workstations (Empower) and corporate IT; DPDP §16 cross-border-transfer evidence for US sponsor data; six-week engagement with two onsite legs

Outcome

Two ALCOA+ contemporaneity exposures on the LIMS-to-CDS time-sync path closed pre-FDA Pre-Approval Inspection; one shared local-admin credential set on three QC workstations rotated and bound to QA witness; zero non-conformities at the subsequent FDA PAI; DPDP §16 evidence pack accepted by the US sponsor's cyber-quality joint committee.

What clients say · Trusted India + UAE

Rated 4.9 ★ from 612 client reviews.

CERT-In Empanelled
Govt of India · MeitY
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Info Security Mgmt
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Aisha Khan
Information Security Manager · Listed Fintech · BKC, Mumbai
The CHFI training Macksofy delivered for our cyber cell raised investigation quality measurably. Practical, India-context-aware, and respectful of our operational realities.
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Inspector K. Joshi
Cyber Cell · Maharashtra Police · Mumbai
Came in with zero security background. 5 weeks later I was running Burp Suite and Metasploit confidently. Cleared CEH on the first attempt.
VI
Vivek Iyer
DevSecOps Lead · Healthcare SaaS · Hyderabad
FAQ

Questions Hyderabad buyers ask before signing.

Yes. Lab-instrument workstation reviews are run as guided walk-throughs with a QA witness, against documented test scripts that do not alter validated state. Findings are documented in 21 CFR Part 11 §11.10(e) terms with the QA witness signature so the evidence is itself part of the validation record.
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